Stress Urinary Incontinence
Conditions
Keywords
Stress urinary incontinence, SUI
Brief summary
This pilot study will evaluate the efficacy of the pessary (disposable intra-vaginal device) by reduction in urine leakage in women with stress urinary incontinence (SUI).
Interventions
DEVICEpessary (disposable intra-vaginal device)
pessary device(disposable intra-vaginal device)manufactured by Procter & Gamble
Sponsors
Procter and Gamble
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* have a ≥ 3 month history of experiencing Stress Urinary Incontinence * be willing to use the pessary investigational device to control stress incontinence
Exclusion criteria
* pregnant, lactating or planning to become pregnant during the study * within 3 months post partum * intrauterine device (IUD) placement of less than 6 months * a history of Toxic Shock Syndrome (TSS) or symptoms consistent with TSS * experience difficulty inserting or wearing an intra-vaginal device, including a tampon * vaginal surgery, perineal surgery, uterine surgery, or abortion (spontaneous or induced) within the past 3 months * has any Screening laboratory value outside the laboratory reference range considered clinically significant by the Investigator * for any reason, the Investigator decides that the subject should not participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pad Weight Gain | from the 14-day baseline period to the last 7 days of 14-day device usage period | Change from baseline as measured as reduction (improvement) in pad weight gain. Positive values are indicative of efficacious outcome. |
| Change in Stress Urinary Incontinence Episodes | from the 14-day baseline period to the last 7 days of 14-day device usage period | Change from baseline as measured as reduction (improvement) in stress urinary incontinence episodes. Positive values are indicative of efficacious outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life as Measured by Incontinence Impact Questionnaire (IIQ-7) | baseline and end-of-treatment | The IIQ-7 is based on 7 questions referring to areas which may have been influenced or changed by accidental urine loss and/or prolapse. These questions are assigned a value of, 0 = 'Not at all,' 1= 'Slightly,' 2 = 'Moderately,' or 3 'Greatly.' The IIQ-7 is scored by taking the average score of items and then multiplying the average by 33 1/3 to put scores on a scale from 0 to 100. A lower score is considered less impact to quality of life and a higher score reflects more impact to quality of life. In the same manner, a reduction in scores from baseline reflects improved quality of life. |
| Change in Stress Urinary Incontinence Episodes | from the 14-day baseline period to the first 7 days of 14-day device usage period | Change from baseline as measured as reduction (improvement) in stress urinary incontinence episodes. Positive values are indicative of efficacious outcome. |
| Change in Pad Weight Gain | from the 14-day baseline period to the first 7 days of 14-day device usage period | Change from baseline as measured as reduction (improvement) in pad weight gain. Positive values are indicative of efficacious outcome. |
Other
| Measure | Time frame |
|---|---|
| Percentage of Responders for Pad Weight Gain | from the 14-day baseline period to the last 7 days of 14-day device usage period |
| Percentage of Responders for SUI Episodes | from the 14-day baseline period to the last 7 days of 14-day device usage period |
Countries
United States
Participant flow
Pre-assignment details
148 subjects entered the 2-week baseline phase and 65 dropped/failed before treatment
Participants by arm
| Arm | Count |
|---|---|
| Pessary Device pessary (disposable intra-vaginal device) | 83 |
| Total | 83 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 5 |
| Overall Study | Protocol Violation | 2 |
Baseline characteristics
| Characteristic | Pessary Device |
|---|---|
| Age, Continuous | 52.7 years STANDARD_DEVIATION 9.25 |
| Sex: Female, Male Female | 83 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 15 / 83 |
| serious Total, serious adverse events | 0 / 83 |
Outcome results
Primary
Change in Pad Weight Gain
Change from baseline as measured as reduction (improvement) in pad weight gain. Positive values are indicative of efficacious outcome.
Time frame: from the 14-day baseline period to the last 7 days of 14-day device usage period
Population: Intent-to-Treat (ITT) population. The Number of Participants Analyzed is the number subjects with available (non-missing) data in week 2
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pessary Device | Change in Pad Weight Gain | 2.67 grams/usage period |
Primary
Change in Stress Urinary Incontinence Episodes
Change from baseline as measured as reduction (improvement) in stress urinary incontinence episodes. Positive values are indicative of efficacious outcome.
Time frame: from the 14-day baseline period to the last 7 days of 14-day device usage period
Population: Intent-to-Treat (ITT) population. The Number of Participants Analyzed is the number subjects with available (non-missing) data in week 2
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pessary Device | Change in Stress Urinary Incontinence Episodes | 0.92 episodes/usage period |
Secondary
Change in Pad Weight Gain
Change from baseline as measured as reduction (improvement) in pad weight gain. Positive values are indicative of efficacious outcome.
Time frame: from the 14-day baseline period to the first 7 days of 14-day device usage period
Population: Intent-to-Treat (ITT) population. The Number of Participants Analyzed is the number subjects with available (non-missing) data in week 1
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pessary Device | Change in Pad Weight Gain | 2.36 grams/usage period |
Secondary
Change in Quality of Life as Measured by Incontinence Impact Questionnaire (IIQ-7)
The IIQ-7 is based on 7 questions referring to areas which may have been influenced or changed by accidental urine loss and/or prolapse. These questions are assigned a value of, 0 = 'Not at all,' 1= 'Slightly,' 2 = 'Moderately,' or 3 'Greatly.' The IIQ-7 is scored by taking the average score of items and then multiplying the average by 33 1/3 to put scores on a scale from 0 to 100. A lower score is considered less impact to quality of life and a higher score reflects more impact to quality of life. In the same manner, a reduction in scores from baseline reflects improved quality of life.
Time frame: baseline and end-of-treatment
Population: Intent-to-Treat (ITT) population. The Number of Participants Analyzed is the number subjects with available (non-missing) data at the end of treatment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pessary Device | Change in Quality of Life as Measured by Incontinence Impact Questionnaire (IIQ-7) | 9.52 units on a scale |
Secondary
Change in Stress Urinary Incontinence Episodes
Change from baseline as measured as reduction (improvement) in stress urinary incontinence episodes. Positive values are indicative of efficacious outcome.
Time frame: from the 14-day baseline period to the first 7 days of 14-day device usage period
Population: Intent-to-Treat (ITT) population. The Number of Participants Analyzed is the number subjects with available (non-missing) data in week 1
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pessary Device | Change in Stress Urinary Incontinence Episodes | 0.65 episodes/usage period |
Other Pre-specified
Percentage of Responders for Pad Weight Gain
Time frame: from the 14-day baseline period to the last 7 days of 14-day device usage period
Population: Intent-to-Treat (ITT) population. The Number of Participants Analyzed is the number subjects with available (non-missing) data in week 2
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pessary Device | Percentage of Responders for Pad Weight Gain | 36.6 percentage of subjects |
Other Pre-specified
Percentage of Responders for SUI Episodes
Time frame: from the 14-day baseline period to the last 7 days of 14-day device usage period
Population: Intent-to-Treat (ITT) population. The Number of Participants Analyzed is the number subjects with available (non-missing) data in week 2
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pessary Device | Percentage of Responders for SUI Episodes | 42.7 percentage of subjects |